MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. SMALL CROSS CONNECTOR; EBI TOP LOADING MAS SPINAL FIXATION SYSTEM

Catalog Number	94671
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during final tightening of a small polaris cross connector, the set screw appeared to be stripped; no audible click was heard.The implant was taken off and a new one was used.There was no reported patient impact.
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed that the device was returned disassembled, however the device was able to be reassembled without incident.All three screws of the assembly were inspected and there was no damage to the threads.Each screw was able to be fully tightened without issue.Root cause: a definitive root cause cannot be determined since the returned device was found to function as expected.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that during final tightening of a small polaris cross connector, the set screw appeared to be stripped; no audible click was heard.The implant was taken off and a new one was used.There was no reported patient impact.

• Brand Name: SMALL CROSS CONNECTOR
• Common Device Name: EBI TOP LOADING MAS SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17711882
• Report Number: 3012447612-2023-00258
• Device Sequence Number: 2149177
• Product Code: NKB
• UDI-Device Identifier: 00888480476320
• UDI-Public: (01)00888480476320(10)J6987546
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K033312
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 94671
• Device Lot Number: J6987546
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/29/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic